ABSTRACT
This chapter examines the validity of the obtaining of informed consent for neonatal research across Europe and to suggest practical improvements if necessary. It also examines the role of Research Ethics Committees, and their role in ethical review in Europe. Progress in medicine is heavily dependent upon research. There are various stages in research on medical treatments. For example, one stage may often be the testing of a treatment on animals. One particular method of research, which is thought by many to give the most reliable scientific evidence, is the randomised controlled trial (RCT). This involves testing treatments against each other and/or against a placebo. Euricon has been looking in particular at parental consent to RCTs involving neonates. This case raises several difficulties. In the first place, what is involved here is sometimes termed ‘proxy consent’. ‘Proxy consent’ occurs when a second party agrees or refuses participation on behalf of the subject who may potentially enter the trial.
